TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P030002/S027 · decided 2013-05-20
Approval details
- PMA number
- P030002
- Supplement
- S027
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS
- Generic name
- LENS, INTRAOCULAR, TORIC OPTICS
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2012-03-27
- Decision date
- 2013-05-20
- Days to decision
- 419 days
- Decision code
- APPR
- Product code
- MJP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODELS: AT50T, BL1AT AND BL1UT) AND TRULIGN TORIC CALCULATOR. THIS DEVICE IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA AND POSTOPERATIVE REFRACTIVE ASTIGMATISM SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH OR WITHOUT PRESBYOPIA WHO DESIRE REDUCTION OF RESIDUAL REFRACTIVE CYLINDER WITH INCREASED SPECTACLE INDEPENDENCE ANDIMPROVED UNCORRECTED NEAR, INT
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| BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI (K122575) | Bausch & Lomb, Inc. | 2012-12-20 |
| BAUSCH & LOMB IOL INJECTOR (K113852) | Bausch & Lomb, Inc. | 2012-09-28 |
| OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION (K112909) | Bausch & Lomb, Inc. | 2012-04-30 |
| EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION (K111877) | Bausch & Lomb, Inc. | 2012-01-24 |